Kornimate/medical-research-clean huggingface dataset:
study of efficacy, safety and tolerability of cmk389 in patients with chronic pulmonary sarcoidosis

Conditions: Pulmonary Sarcoidosis

Summary: the purpose of this proof of concept study was to determine whether cmk389 displays the safety and efficacy profile to support further development in chronic pulmonary sarcoidosis.

this was a subject and investigator blinded, randomized, placebo-controlled, parallel-group, repeat-dose, multicenter, non-confirmatory study of cmk389 in chronic pulmonary sarcoidosis. this study investigated the safety and efficacy of 10 mg/kg cmk389 administered intravenously (i.v.) every 4 weeks for a total of 4 doses, versus placebo

Eligibility criteria:
inclusion criteria: * subjects must have a body mass index (bmi) at screening within the range of 18 - 46 kg/m2. bmi = body weight (kg) / \[height (m)\]2 * biopsy proven pulmonary sarcoidosis diagnosed \> 1 year prior to screening * scadding stage ii, iii or iv as determined by the most recent chest x-ray obtained within 12 months prior to screening or at screening (confirmed by the investigator) * hrct extent of fibrosis \<20% (confirmed by the central imaging reader) at screening * treatment with 5-15 mg/day prednisone (or prednisone oral equivalents) for ≥ 6 months prior to screening. * co-medication with methotrexate or azathioprine for ≥ 6 months prior to screening (note: hydroxychloroquine is allowed as background therapy but not required) * able to perform reliable, reproducible pulmonary function test maneuvers per american thoracic society/european respiratory society (ats/ers) guidelines exclusion criteria: * diagnosis of significant pulmonary hypertension (who group 5) requiring pharmacological treatment * active cardiac sarcoidosis requiring treatment. inactive cardiac sarcoidosis or stable cardiac sarcoidosis not requiring treatment are permissible. * a known diagnosis of neurosarcoidosis * forced vital capacity (fvc) \<50% of predicted at screening (central read) * modified british medical research council (mmrc) dyspnea scale ≥ 3 at screening * concomitant treatment with leflunomide, cyclophosphamide, mycophenolate, infliximab, etanercept, adalimumab, golimumab, ustekinumab, roflumilast, pentoxifylline, and abatacept within 12 weeks of screening * prior treatment with rituximab, canakinumab, anakinra, and tocilizumab * current use of any inhaled substance, including but not limited to tobacco, marijuana products and use of electronic cigarette or vaping device, and excluding inhalers or nebulizers prescribed for pulmonary sarcoidosis * any conditions or significant medical problems which in the opinion of the investigator and in consultation with the sponsor, immunocompromises the patient and/or places the patient at unacceptable risk for immunomodulatory therapy * contraindication to fdg-pet scan investigations such as severe claustrophobia or uncontrolled diabetes * history or current diagnosis of ecg abnormalities not due to cardiac sarcoidosis and indicating significant risk of safety for patients participating in the study * a diagnosis of lofgren's syndrome * a history of pancreatitis

Keywords: chronic pulmonary sarcoidosis
impact of emotional skills of young women and their partner on adjustment to cancer

Conditions: Aging; Breast Cancer

Summary: the kalicou 3 study will evaluate the effect of emotional skills of patients and their partners on their individual disease subjective experience during care pathways, from chemotherapy to surveillance.

all women with breast cancer have to face, at any age, to numerous issues linked to cancer (incertitude, recurrence anxiety...) and to physical and psychosocial side effects of treatments which can degrade their life quality. however, young women (\<45 years at diagnostic) have to face specific issues related to their age (early menopause, withdrawal of pregnancy projects, education of young children). moreover, treatment consequences can alter patient's life quality and can persist in time (fatigue, pains, chemotherapy, sexuality, induced menopause for example). overall, young patients have a lesser life quality, greater emotional distress and vulnerability and have more difficulties to establish adapted adjustment strategy compared to elder women. the role and importance of relatives, particularly partners, during cancer pathology is incontestable. however, few empiric and consensual data exist on the impact of cancer diagnostic on partners, especially when women are young at initial diagnostic. nevertheless, available data underline the importance of the supporting partner during breast cancer disease. cancer also disturbs conjugal relationship. for example, life quality of patient influence strongly the life quality and mental well-being of her partner. moreover, the intimate relation with the partner could play an important role in healing after breast cancer. numerous authors underline the importance of focus on the couple instead of patients alone or partners alone with a dyadic approach where dyad member's reactions will be interdependent. thus, study of dyadic adjustment of couples where a member is facing cancer pathology at young age is indubitably innovative and present a real scientific and clinical interest. more precisely, kalicou 3 study will focus on the impact of intrapersonal and interpersonal emotional skills of patients and partners on individual and dyadic adjustment.

Eligibility criteria:
inclusion criteria: * patient and partner ≥ 18 years. * patient ≤ 45 years at diagnostic of non metastatic breast cancer. * disease relevant for neoadjuvant or adjuvant chemotherapy following or not by radiotherapy or hormonotherapy. * heterosexual or homosexual couples in a relationship since at least 6 months at the date of inclusion * patient affiliate to french social welfare system * informed consent sign by patient and partner before any study procedure exclusion criteria: * psychological or physical inability to fill questionnaire * patient under guardianship
hemodialysis-based interventions to preserve cognitive function

Conditions: Kidney Failure, Chronic

Summary: this will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (hd). the investigators will test two interventions (cognitive training and exercise training) against the standard of care.

this will be a pilot, single center, randomized, controlled trial to slow cognitive decline in adults undergoing hemodialysis (hd). the investigators primary objective is to demonstrate feasibility for the interventions (cognitive training and exercise training) in aim 1. the investigators will formally test whether whether cognitive training (tablet-based brain games) and exercise training (stationary foot pedal) administered during hd slow cognitive decline as well as improve secondary outcomes (physical function, frailty, and health-related quality of life (hrqol) as part of aim 2. the investigators will compare these two interventions against the standard of care. pre- and post-intervention assessments will be conducted at the dialysis unit by a study coordinator and by research assistants. participants will be followed for 6 months to assess cognitive decline.

Eligibility criteria:
inclusion criteria: * men and women with end stage renal disease and receiving hemodialysis at the davita dialysis centers located at 409 n. caroline st., baltimore, md will be approached by our study coordinator to determine eligibility. * must be at least 18 years or older at enrollment * must be english speaking * must be willing to participate in research and able to give informed consent exclusion criteria: * chronic lung disease requiring oxygen * cerebrovascular disease * musculoskeletal conditions that limit mobility * lower or upper extremity amputation * orthopedic disorders exacerbated by physical activity * decreased mental capacity * dementia (diagnosed)
part of the modern art study

Conditions: HCC - Hepatocellular Carcinoma; Liver Metastases

Summary: one of the possible treatments for patients with liver tumours (hepatocellular carcinoma (hcc) or liver metastases) at the erasmus mc is stereotactic body radiation therapy (sbrt) on the cyberknife. to spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted. the ethos treatment system is equipped with a novel cone-beam ct (cbct), which provides higher quality images. this makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more. liver tumours move with the breathing motion. on the cyberknife, a tracking technology is used to keep track of the tumour, but this is not available on the ethos. because of this, breath holds will be used for breathing management, but appropriate safety margins need to be established under the new treatment conditions. the aim of this study is to determine the reproducibility of the tumour position for each breath hold within a treatment fraction, and also between treatment fractions, which is a crucial component in the establishment of appropriate safety margins.

rationale: one of the possible treatments for patients with liver tumours (hepatocellular carcinoma (hcc) or liver metastases) at the erasmus mc is stereotactic body radiation therapy (sbrt) on the cyberknife. to spare the organs at risk, suboptimal coverage of the planning target volume is sometimes accepted on the cyberknife. the ethos therapy linear accelerator is equipped with a novel cone-beam ct (cbct), which provides higher quality images. this makes it possible to consider online adaptive radiotherapy with daily plan adaptation, potentially leading to a higher dose on the tumour whilst sparing the surrounding healthy tissue more. objectives: to determine inter- and intra-fraction fiducial and patient position reproducibility in order to determine appropriate safety margins for liver sbrt treatment on ethos. study design: a prospective, single arm cohort study. study population: ten patients, either with liver metastases (all ages), or age ≥ 65 years with hcc, who are referred to the department of radiotherapy for sbrt, able to comply with breath-hold requirements and not eligible for liver transplantation or curative surgery. intervention: nine cbcts for each patient in end-exhalation breath hold on t main study parameters/endpoints: the primary parameters are inter- and intra-fraction fiducial position reproducibility on the ethos.

Eligibility criteria:
inclusion criteria: * written informed consent; * patient discussed in multidisciplinary tumor board; * patient diagnosed with liver metastases and referred to the dept. of radiotherapy for sbrt or patient ≥65 years, diagnosed with hcc and referred to the dept. of radiotherapy for sbrt; * able to comply with breath-hold requirements. exclusion criteria: * eligibility for surgery, ablation or liver transplantation.

Keywords: hcc - hepatocellular carcinoma stereotactic body radiation therapy breath hold liver metastases
evaluating 18f-fdg pet/ct with liver suvmax-based criteria for prognosis of patients with natural killer/t-cell lymphoma

Conditions: Lymphoma, Extranodal NK-T-Cell

Summary: the purpose of this study is to evaluate whether a semi-quantitative interpretation using the liver suvmax as reference can better interpret 18f- fdg pet/ct and predict disease progression during chemotherapy or survival in nk/t-cell lymphoma.

in this study investigators develope a semi-quantitative interpretation using the liver suvmax as reference to interpret 18f-fdg pet/ct. positive lesions in pet were indicated as suvmax of residues higher than the threshold or new 18f-fdg avid lesions. investigators compare the prognostic accuracy of the liver suvmax-based criteria with the 5-ps criteria and δsuvmax interpretation with respect to predicting disease progression during chemotherapy or survival in nk/t-cell lymphoma. furthermore,investigators improve the prognostic ability of interim pet/ct by comparing the results to the clinical prognostic factors.

Eligibility criteria:
inclusion criteria: * newly diagnosed nk/t-cell lymphoma * treated using an anthracycline-containing regimen * minimal follow-up at 6 months after the completion of first-line treatment * complete medical history and clinicopathological data exclusion criteria: * secondary malignant disease * serious infection or inflammation (e.g., hiv) * primary central nervous system lymphoma * hepatic or renal dysfunction.

Keywords: lymphoma, extranodal nk-t-cell positron-emission tomography prognosis
overgeneralization of conditioned fear as a pathogenic marker of anorexia nervosa

Conditions: Anorexia; Generalized Anxiety

Summary: anorexia nervosa is a chronic mental health condition characterized by maladaptive food consumption (i.e., hypophagia) and distorted body image. there is substantial evidence of a phenotypic overlap between anorexia nervosa and anxiety disorders, as well as data suggesting the two share a common genetic pathway. despite these findings, little research has examined fear conditioning among individuals with anorexia nervosa, and no research has examined whether individuals with anorexia nervosa have a propensity to overgeneralize conditioned fear stimuli, one of the more robust fear-conditioning markers of anxiety disorders. the current study assesses generalization of conditioned fear with fear-potentiated startle: the cross-species enhancement of the startle reflex when an organism is in a state of fear. animal data, as well as an emerging literature in humans, tightly links fear-potentiated startle to the amygdala-based fear circuit. thus, evidence of overgeneralized fear-potentiated startle in anorexia nervosa would link this eating disorder to hypersensitivity of the fear circuit and could inform the development of novel pharmacologic and psychological treatments for anorexia nervosa based on treatment models used in the anxiety disorders literature.

the overarching objective of the current proposal is to examine the feasibility of applying a generalization of conditioned fear-potentiated startle paradigm, which has been used successfully to measure the sensitivity of fear networks in anxiety disorders, to adults with anorexia nervosa. the specific aim will be to examine whether conditioned-fear generalization gradients in anorexia nervosa participants differ from those in healthy controls. it is hypothesized that anorexia nervosa participants will display stronger generalization as indicated by less quadratic generalization gradients (i.e., a more gradual decline in conditioned fear as the generalization stimuli deviate from the conditioned fearful stimuli), which is indicative of a heightened sensitivity, or lower thresholds of activation, in the fear circuit (i.e., less danger information necessary to trigger the fear).

Eligibility criteria:
inclusion criteria: * adults (age≥18) a. anorexics * meet criteria for diagnostic and statistical manual (dsm-5) anorexia nervosa b. controls * age matched * sex-matched exclusion criteria: * criteria are met for a current or past axis i disorder. * inability to read english * pregnancy/lactation * acute suicidality * medical instability as determined by a medical history visit and serum electrolyte testing, * medical conditions that may place the participant at risk (e.g., cardiovascular condition) * current use of medication that alter central nervous system function

Keywords: anorexia generalized anxiety fear
effect of intravitreal bone marrow stem cells on ischemic retinopathy

Conditions: Ischemia

Summary: this study aims to evaluate the behavior of the intravitreal use of bone marrow derived stem cells in patients with ischemic retinopathy.

evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 30 patients with ischemic retinopathy, including diabetic retinopathy with severe loss of retinal capillaries undergoing intravitreal injection of bone marrow derived stem cells.

Eligibility criteria:
inclusion criteria: * diagnosis of ischemic retinopathy * enlargement of foveal avascular zone-faz (ischaemia or capillary drop out of \>30% on fluorescein retinography * logarithm of minimum angle of resolution (logmar) bcva of 1.0 (snellen equivalent, 20/200) or worse * able (in the investigator's opinion) and willing to comply with all study requirements exclusion criteria: * previous ocular surgery other than cataract * presence of cataract or other media opacity that would influence ocular fundus documentation and adequate erg and visual field evaluation * other ophthalmic disease like glaucoma and uveitis * previous history of blood disorders like leukemia * known allergy to fluorescein or indocyanine green

Keywords: ischemic retinopathy, stem cell,bone marrow
malnutrition and outcome in hospitalized children in europe

Conditions: Malnutrition

Summary: malnutrition in children has even more severe consequences on disease course and long-term health than malnutrition in adults. according to prior studies, malnutrition affects about 15-30 % of hospitalized children in europe (espghan 2005, pawellek et al 2008, joosten and hulst 2008). however, available criteria for defining malnutrition in paediatric patients are inconsistent, not based on firm evidence, and not generally agreed upon. current guidelines do not address assessment of and screening for childhood malnutrition. therefore, a large number of affected children are not adequately diagnosed. one aim of this study is to assess the prevalence of malnutrition and patients at risk for malnutrition among at least 2700 hospitalized children mainly across europe. in addition criteria to link anthropometric measurements and the prediction of outcome, i.e. length of hospital stay, shall be established. a further goal then is to establish agreed, evidence-based criteria for malnutrition in children with the purpose of leading to an agreed, evidence-based screening tool for paediatric malnutrition in developed countries. this tool shall include a set of simple questions, based on previously suggested tools. thereby this study will provide a strong basis for implementing evidence-based nutritional interventions in paediatric patients by harmonisation of diagnostic criteria for childhood malnutrition in developed countries.


Eligibility criteria:
inclusion criteria: * children admitted to the participating hospitals during the study period * age between 1 month and 18 years * expected hospital stay exceeding 24 hours * parents/caregivers, as well as those patients capable to comprehend, agree to participation and sign the informed consent form exclusion criteria: * infants with premature birth (\<37 weeks gestational age) during the first 12 months of life * infants \< 1 month of age * patients ≥ 18 years of age * children in need of intensive care * children admitted to day-care (los \< 24hours) * patients admitted for elective reasons with an expected hospital stay \<24 hours

Keywords: malnutrition children hospital stay screening tools anthropometry
the effect of melatonin on postoperative delirium in elderly icu patients

Conditions: Delirium

Summary: delirium in older patients is associated with increased mortality and health care costs. and delirium is frequent in intensive care unit (icu). circadian rhythm alteration is one of the most important risk factor for developing delirium. in this study, investigators will investigate the effect of administration of melatonin on postoperative delirium in elderly icu patients. randomly selected patients of the melatonin group are given 5mg of melatonin in the evening from the day before surgery to the the 5th postoperation day. in contrast, patients in the control group are given placebo. primary outcome of this study is the incidence of postoperative delirium measured by icd-sc (intensive care delirium screening checklist). and secondary outcome includes intra-procedural hemodynamics measured by amount of used vasopressors, heart rate and blood pressure, total amount of sedatives, total amount of analgesics, duration of mechanical ventilation, duration of icu stay. thus, investigators perform this study to investigate the relationship between delirium and circadian rhythm.


Eligibility criteria:
inclusion criteria: * older than 50 years old * patients who admitted to icu after surgery exclusion criteria: * subjects are ineligible if they have cognitive dysfunction, * disabling mental change disorder, * alcohol addiction, * dementia, * cerebrovascular accident, * transient ischemic attack, * carotid artery stenosis, * autoimmune disease, * patients who are unable to communicate or speak korean, * emergent operation

Keywords: elderly icu patients
study to assess treatment patterns and outcomes with upadacitinib in adult participants with inflammatory bowel disease in belgium

Conditions: Ulcerative Colitis; Crohn's Disease

Summary: crohn's disease (cd) is an incurable chronic inflammatory disorder of the gastrointestinal tract. ulcerative colitis (uc) is an idiopathic, chronic, inflammatory disease affecting the colon. this study will assess the (long-term) effectiveness and safety of upadacitinib in real-world clinical practice in adult participants with moderate to severe ulcerative colitis (uc) and crohn's disease (cd). upadacitinib is an approved drug for treating ulcerative colitis (uc) and crohn's disease (cd). approximately 280 participants who are prescribed upadacitinib by their physician in accordance with local label will be enrolled in 8 sites across belgium. participants will receive upadacitinib as prescribed by their physician according to their routine clinical practice and local label. participants will be followed for up to 3 years. there is expected to be no additional burden for participants in this trial. participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice


Eligibility criteria:
inclusion criteria: * participants with a diagnosis of moderate to severe crohn's disease or ulcerative colitis, initiated with upadacitinib at least 12 months prior to inclusion, including participants that were initiated on upadacitinib, but later (i.e. at the moment of data collection) discontinued, or switched to another treatment. * participants initiating commercially available upadacitinib at the clinician's discretion as part of their routine clinical care; the decision to administer upadacitinib must be made prior to and independent of recruitment into the study * participants prescribed upadacitinib in accordance with the approved local label and treatment recommendations exclusion criteria: * participants previously exposed to upadacitinib in a clinical trial or early access program * participants participating in interventional research (not including non-interventional * participants with stoma

Keywords: ulcerative colitis crohn's disease upadacitinib rinvoq
institut paoli calmettes lymphoma database

Conditions: Lymphoma

Summary: database of institut paoli-calmettes patients diagnosed with lymphoma


Eligibility criteria:
inclusion criteria: * hodgkin or non-hodgkin lymphoma exclusion criteria: * non applicable